Beth Israel Deaconess Medical Center, Inc.

SAN DIEGO — As researchers explore more potential benefits of GLP-1 medicines, a new retrospective study is suggesting the drug class’ potential to treat venous thromboembolisms, or blood clots in the veins, for individuals with type 2 diabetes. The researchers looked at electronic health records from hundreds of thousands of diabetes patients and compared those who took GLP-1s with another diabetes drug class known as DPP-4 inhibitors. The review found that those who were on GLP-1 drugs had a 20% lower risk of developing the clots after one year. That group also had a 22% lower rate of pulmonary embolisms — clots blocking arteries in the lungs — and an 18% lower rate of deep vein thrombosis. Retrospective studies like this one are useful for finding relationships and suggesting avenues for further study, but the evidence is often considered less persuasive than a randomized, placebo-controlled study. The research was published at the American Society of Hematology annual meeting this weekend. DPP-4 inhibitors were chosen as a control group because they are a commonly used diabetes drug and have no known effect on venous thromboembolisms, lead author Cho Han Chiang told Endpoints News . The research also didn’t separate results by specific GLP-1 drugs. All previously approved drugs were included in the analysis, including newer ones like semaglutide (Novo’s Ozempic and Wegovy) and tirzepatide (Eli Lilly’s Mounjaro and Zepbound), as well as GLP-1s approved in the mid-2000s like exenatide (Lilly’s Byetta). Chiang also included patients who were taking other diabetes drugs like metformin or insulin. The results add to a quickly growing body of evidence that GLP-1 drugs could have broad applications beyond the diabetes and obesity indications that make up the bulk of the market for the drugs. In March, the FDA approved Wegovy to treat cardiovascular disease, and other data have shown potential effects in conditions ranging from liver disease to Parkinson’s and depression. Chiang, a resident at Beth Israel Deaconess Medical Center in Boston, said diabetes and obesity are significant risk factors for venous thromboembolism, one of the reasons he decided to conduct the analysis. There aren’t many medical interventions that can prevent them, he said. “There are some recommendations on the use of low molecular weight heparin and compression stockings,” Chiang said. “But in terms of medical therapy to reduce one of the major risk factors, such as obesity, in contributing to VTE, there’s pretty limited data.” The CDC estimates that there are as many as 900,000 yearly cases of venous thromboembolisms in the US. The next step in Chiang’s research will be to look at conducting a similar analysis specifically for obesity, he said. Other areas where venous thromboembolisms can manifest are some hematological cancers. But whether biopharma companies opt to conduct clinical trials is up to their discretion, he said. “You probably can randomize patients on GLP-1 receptor agonists, and those without, as an add-on therapy to a diabetes regimen” in patients at high risk for developing venous thromboembolisms, Chiang said.

Groundbreaking NEJM AI Study Highlights the Ability of Prenosis' Sepsis ImmunoScore™ to Holistically Predict Adverse Outcomes, Ushering in a New Era of Predictive Sepsis Tools Powered by AI CHICAGO, Dec. 4, 2024 /PRNewswire/ -- A new study published in the New England Journal of Medicine AI (NEJM AI) concluded the Sepsis ImmunoScore™, the first FDA-authorized AI diagnostic for sepsis, has high accuracy for the diagnosis of sepsis and for prediction of key adverse patient outcomes, concretely demonstrating the benefit of AI to inform sepsis care. Sepsis, an overactive immune response to infection, costs the U.S. healthcare system billions of dollars annually and claims the lives of at least 350,000 people each year—more than all cancers combined. The peer-reviewed study—FDA-Authorized AI/ML Tool for Sepsis Prediction: Development and Validation—found the Sepsis ImmunoScore™ has high accuracy for sepsis diagnosis and simultaneously predicted critical outcomes, including mortality during hospitalization, length of stay before discharge, ICU admission, need for mechanical ventilation, and use of vasopressors. This represents the first time an FDA-authorized tool for sepsis can predict all of these critical outcomes simultaneously. This milestone publication underscores the potential of Prenosis Inc.'s Sepsis ImmunoScore™ to transform sepsis management by presenting providers with trustworthy predictive information, allowing them to shift from a reactive to a proactive approach to care. While single biomarkers, such as Procalcitonin (PCT), have been valuable tools in diagnosing sepsis for over two decades, they have limitations when trying to predict the future. The study demonstrated the combination of multidimensional inputs—vital signs, lab data, and sepsis-specific biomarkers—into a comprehensive AI-driven tool provides more reliable diagnostic information and is predictive of future patient outcomes. "The Sepsis ImmunoScore™ is the first FDA-authorized sepsis AI algorithm that functions by embedding in the EMR and is approved to aid providers in the identification and assessment of patients with sepsis," said Nathan I. Shapiro, MD, MPH, a Professor of Emergency Medicine at Harvard Medical School and attending physician in the Department of Emergency Medicine at Beth Israel Deaconess Medical Center, and the paper's corresponding author1. "For too long, clinicians have struggled with the early and accurate prediction of adverse outcomes due to sepsis, a complex, rapidly progressing condition," said Bobby Reddy, Jr., Prenosis Co-Founder and CEO. "By delivering FDA validated AI results with transparency and explainability for clinicians, tools like the Sepsis ImmunoScore™ offer critical insights to improve patient outcomes." "Hospitals and clinicians now have access to the first-ever FDA-authorized, peer-reviewed AI solution that provides unmatched insights into sepsis risk and prediction of the negative outcomes associated with sepsis," said Akhil Bhargava, the study's lead author. "This study confirmed that AI, when validated, can be a reliable, comprehensive tool to assist providers with identification of patients at high risk of sepsis and prediction of sepsis-related adverse outcomes," added Bhargava, Prenosis' Senior Data Scientist — Applied Machine Learning. About the Sepsis ImmunoScore™ FDA-authorized via the De Novo pathway in April 2024, the Sepsis ImmunoScore™ outputs a combination of both diagnostic and predictive information previously unavailable in a legally marketed device for sepsis. Unlike early warning systems that alert clinicians to potential sepsis with high amounts of false positives, leading to alert fatigue, the Sepsis ImmunoScore™ delivers actionable and trustworthy insights. The Sepsis ImmunoScore™ works in concert with a clinician's suspicion of serious infection, providing information exactly when needed for decision-making. The Sepsis ImmunoScore™ was built using Prenosis' Immunix™ platform, which enables precision medicine in acute care. Immunix™ facilitates the development and validation of new precision solutions, such as AI biomarkers, and their real-time implementation. Over a decade of collaboration with more than ten U.S. partner hospitals, Prenosis used Immunix™ to build a proprietary biobank and dataset of over 113,000 blood samples from more than 28,000 patients. Prenosis merges biological data extracted from these samples with clinical information from Electronic Medical Records, creating the world's largest biological-clinical dataset for acute care patients with suspected serious infections. This dataset enables the development of AI algorithms to detect rapid immune responses and recommend personalized therapies in real time in hospitals and emergency departments. About Prenosis Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. We believe healthcare should be tailored to individual biology. Our data-driven approach to fast-moving biology in acute care is ushering in a new era of precision medicine. Powered by our Immunix™ precision medicine platform, we generate proprietary biological insights that drive the development of precision products and enable real-time delivery of optimal therapy. With Immunix™, we created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™. For more information, visit: 1 Disclosure: Shapiro holds private equity in and consults for Prenosis. SOURCE Prenosis WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MONDAY, Nov. 25, 2024 -- The U.S. Food and Drug Administration has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa . Bimzelx becomes the first and only approved medicine designed to selectively inhibit interleukin 17F in addition to interleukin 17A and is the fifth indication for Bimzelx in the United States. The approval is supported by data from two phase 3 studies of adults with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II). Compared with placebo, results showed that a higher proportion of patients treated with Bimzelx achieved ≥50 percent improvement in signs and symptoms of hidradenitis suppurativa at week 16, which was the primary end point as measured by Hidradenitis Suppurativa Clinical Response (HiSCR50). Bimzelx treatment also resulted in clinically meaningful improvements in the secondary end point, HiSCR75 at week 16, compared with placebo. Clinical responses were sustained to week 48, with no new safety signals reported. "The approval of Bimzelx in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today," BE HEARD investigator Alexa B. Kimball, M.D., from the Beth Israel Deaconess Medical Center in Boston, said in a statement. Approval of Bimzelx was granted to UCB. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.